Get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials
11 - 13 Sep 2024
or
9 - 11 Dec 2024
On location
Danish
(app. 2,716 EUR ex VAT)
At this course, you get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course consists of presentations from authorities and experts in clinical trials complemented by group work and cases.
The starting point of this course is current legislation and guidelines and the different roles and responsibilities of monitors and investigators/study nurses.
Furthermore, focus is on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimise your collaboration with your partners.
To achieve a Diploma you must pass the exam, which is held approximately four weeks after the course. The exam must be purchased separately . If you do not take the exam, you will receive a certificate of completion.
"It was a very well-planned course with good lectures and course leaders who had a great overview and managed the course very well."
Pernille Videbæk Pedersen, GCP-Coordinator, Aarhus University.
"It was a very well-structured course, which academically had a high level."
Pernille Skovby, National Coordinator at DanPedMed.
"Good and relevant professional content. Informative to meet with stakeholders from both the clinic, authorities, public and private sectors."
Sara Jensen, Project Nurse, Sygehus Lillebælt
We are excited every time one of our course participants completes a diploma: You've made a significant investment in yourself, and that deserves recognition. That's why we host a diploma ceremony twice a year. You can find available dates and register here. At the event, you'll receive your diploma, and we'll provide some refreshments. Feel free to bring your family along.
Should you prefer to receive you diploma via mail, this is, of course, also possible.
This diploma course is a basic training aimed at new monitors, project nurses, and investigators. It is an advantage to have some experience in the field.
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Experience with contractual relations in clinical trials is an advantage, but not a requirement.
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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10 Oct 2024
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